Recall - "Baby Magnesia", "Vai Lafa", "Vai Tane"
11 December 2008
Health warning issued under Section 98 of the Medicines Act 1981
The Director-General of Health, Stephen McKernan, is warning the public about the potential health dangers associated with three unapproved medicines manufactured in a pharmacy in Samoa and sold from general retailers in New Zealand.
This statement about the three medicines is being issued by the Director-General under Section 98 of the Medicines Act 1981, following an investigation by the Ministry of Health's medicines safety arm, Medsafe.
The three medicines are labeled as originating from ‘Maria’s Healthcare Pharmacy Ltd’ in Apia. They have been imported by a wholesaler and distributed in New Zealand to various retail outlets.
The products are:
• ‘Baby Magnesia’, a product that is
labelled as being suitable for babies as young as 3 months
for the relief of ‘wind and tummy pains’. The
label states that the product contains the ingredients:
citric acid, sodium bicarbonate and magnesium carbonate.
• ‘Vai Lafa’, a product intended for the treatment of ringworm. The label states that the product contains 15% Salicylic Acid.
• ‘Vai Tane’, a product intended for the treatment of fungal infections. The label states that the product contains 10% Salicylic Acid.
The safety, quality and efficacy of these medicines are unknown as they have not been assessed and approved for supply in New Zealand through the medicines approval process.
In particular, the ‘Baby Magnesia’ product is labelled for use in young babies and has not had the rigorous assessment required for medicines used in such circumstances. The Director-General believes that without these comprehensive safeguards, this product poses a safety risk to babies and young children.
The Vai Lafa and Vai Tane products pose a safety risk because they are not adequately labelled with instructions for use and these products have not been assessed and approved for the treatment of ringworm or fungal infections. Medicines sold in New Zealand must be correctly labelled and comply with safety requirements.
"Consumers should immediately stop using the products and seek medical advice from their doctor if they or their babies and children have been unwell when using any of these products,"said Mr McKernan.
This warning also applies to other similar medicines that may be on sale in New Zealand. Consumers are advised not to buy any medicines that have an overseas pharmacy label, have a pharmacy label but are not being sold by a pharmacy or have a label that does not have instructions for use in English as these medicines will not have been approved for sale in New Zealand. Medsafe would welcome information from consumers about the sale of any such medicines being supplied in this manner.
Link to product photos: http://www.medsafe.govt.nz/alerts/samoan/photos.asp
Questions and Answers
What is wrong with these products?
All three products are being sold illegally as they have not been approved for sale through the New Zealand medicines approval process.
Baby Magnesia is being sold for the treatment of ‘wind and tummy pain’ in babies and young children. The manufacturing standards for this medicine have not been assessed and so no assurance can be given about its quality. It is labelled with a two year expiry date which is inappropriate because it may deteriorate during that time or become contaminated with bacteria during use.
Vai Lafa and Vai Tane contain salicylic acid in a flammable alcohol solution and are intended for the treatment of ringworm and fungal infection. There are no instructions for use. These medicines have not been assessed and approved for the treatment of ringworm or fungal infections and may not be effective. The conditions under which these products have been manufactured have not been assessed so their quality cannot be guaranteed.
If a consumer is taking or using one of these products what should they do?
Consumers are being warned to immediately stop taking or using these products and seek medical advice from their doctor if they, or their babies or children have felt unwell when using the products.
Information so far indicates that approximately 520 bottles of Baby Magnesia and 130 bottles each of Vai Lafa and Vai Tane have been sold to consumers.
Adverse reactions to these products should be reported to the Centre for Adverse Reactions Monitoring: www.carm.otago.ac.nz
Consumers can also report any concerns to Medsafe: www.medsafe.govt.nz
Have these products been removed from sale?
Stock distributed by one wholesaler and sold through retail outlets has been recalled from those outlets.
It is possible that other similar unapproved products may be on sale. Medsafe welcomes any information from consumers about the sale of such products.
Medsafe is continuing to investigate the matter and may take further regulatory action if required.
Important advice to traders
Under the medicines legislation, manufacturers, distributors and importers are required to obtain approval before they sell or distribute products intended for a therapeutic purpose. Retailers cannot lawfully sell products that have not first been approved for sale under the provisions of the Medicines Act 1981.
Under section 20 of the Medicines Act 1981, Ministerial consent is required for the sale or distribution of new medicines in New Zealand.
A breach of this requirement carries substantial penalties.
An individual who sells, distributes or advertises the availability of any medicine without Ministerial consent is liable on conviction to imprisonment for a term not exceeding 6 months or a fine not exceeding $20,000.
A body corporate which sells, distributes or advertises the availability of any medicine without Ministerial consent is liable on conviction to a fine not exceeding $100,000.
The Ministry of Health takes breaches of the medicines laws very seriously, especially where patient and consumer safety is put at risk, and regulatory action will be taken as necessary to ensure compliance.